Ohayou Gozaimasu. This week the term specific to Japan, the doctor would like to introduce to the readers is “Todokede.” Todokede is the pre-market submission process associated with Class I devices in Japan.
As many of the readers already know, Dr. D spends much of his time on the road advising clients how to comply with regulatory requirements, implementing quality management systems (QMS), and auditing client’s and/or their supplier’s QMSs to a variety of regulatory requirements and recognized standards. That being said, the doctor believes that product realization is probably one of the more overlooked and least understood of requirements device manufacturers are mandated to comply with.
However, without an effective process for product realization, it is a daunting and nearly impossible task of understanding, identifying, documenting, planning, implementing, allocating, risk managing, validating, verifying, manufacturing, testing, inspecting, and shipping, medical devices that are safe and effective. Has the doctor provided enough words ending in “ing” for the readers? Seriously folks, product realization is all about the planning (Dr. D’s humble opinion) and the establishment of an effective approach for communicating with the customer. Device manufacturers that pursue a vanward (look-it-up) approach to quality management will clearly be ahead of the rest of the pack when it comes to complying with Ministerial Ordinance 169 (MO 169). Remember, if an organization wants to enter medical devices into the Japanese device market, there is only one true path. That true path my friends is complying with all aspects of MO 169 (as applicable).
Ministerial Ordinance Number 169 (2004)
Chapter Two “Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufacturers, etc.”
Section Five – Product Realization
(Planning of Product Realization)
Article 26 The manufacturer, etc. shall plan and develop the processes needed for the product realization (the duties of the manufacturer, etc. for realization of the products).
2. The manufacturer, etc. shall ensure that the planning of the product realization specified in preceding Paragraph 1 (hereinafter referred to as “planning of product realization”) is consistent with the requirements of the other processes of the quality management system.
3. The manufacturer, etc. in case where they conduct planning of product realization, shall determine the following items, as appropriate.
- The quality objectives and requirements for the products,
- The need to establish the processes, QMS documents, and provide resources specific to the products,
- The required verification, validation, monitoring, inspection and test activities specific to the products and the criteria for the product acceptance (hereinafter referred to as the “manufacturing site release criteria”),
- The records needed to provide evidence that the realization processes and resulting products meet the product requirements.
4. The manufacturer, etc. shall ensure that the output of the planning of product realization is in a form suitable for the manufacturing site’s method of the operations.
5. The manufacturer, etc. shall establish the documented requirements for the risk management throughout the product realization.
6. The manufacturer, etc. shall ensure that the records arising from the risk management are maintained.
(Determination of Requirements Related to the Products)
Article 27 The manufacturer, etc. shall determine the following items as the product requirements.
- The requirements specified by the customer, including the requirements for delivery and post-delivery activities,
- The requirements not stated by the customer but necessary for the specified or intended use, where known,
- The regulatory requirements related to the products, and
- Any additional requirements determined by the manufacturer, etc.
(Review of Requirements Related to Products)
Article 28 The manufacturer, etc. shall review the product requirements, prior to their commitment to supply the products to the customer.
2. The manufacturer, etc. shall, in case where they conduct the review specified in preceding Paragraph 1, ensure the following items.
- To be ensured that the product requirements are defined and documented,
- To be ensured that the contract or order requirements of the customer differing from those previously expressed are resolved, and
- To be ensured that the manufacturing site has the ability to meet the defined requirements.
3. The manufacturer, etc. shall ensure that the records of the results of the review specified in preceding Paragraph 1 and the actions arising from the review are maintained.
4. Where the customer provides no documented statement of the requirement, the manufacturer, etc. shall confirm the customer requirements before the acceptance.
5. Where the product requirements are changed, the manufacturer, etc. shall ensure that the relevant documents are amended and that relevant personnel are made aware of the changed requirements.
Article 29 The manufacturer, etc. shall determine and implement the effective arrangements for communicating with the customers in relation to the following items.
- The product information,
- The enquiries, contracts or order handling, including the amendments,
- The customer feedback, including the customer complaints, and
- The issuance and implementation of the advisory notices specified in Paragraph 2 of Article 62.
What device manufacturers need to know
For those of you well-versed in EN ISO 13485:2003, once again you will quickly see the similarities between MO 169’s requirements for product realization and the ISO requirements. In many instances, the Japanese requirements for product realization mimic the requirements delineated within ISO 13485, word-for-word. Go figure. Regardless, it all commences with adequate planning. Dr. D would like to remind the readers of an old quote (note sure who wrote it); “Failing to properly plan is a plan for failure.” Truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.
For starters, the product realization process, including the planning, must be consistent with an organization’s QMS. As part of the planning process, device manufacturers are expected to:
- Establish requirements and quality objectives for each of their products;
- Establish processes, including providing resources specific to products;
- Execute verification, validation, monitoring, testing, inspection, and other activities needed in support of product acceptance; and
- Retain records of these activities to support that product realization activities were actually performed.
Remember a fundamental goal of product realization activities is to identify and implement all of the processes needed to successfully manufacture devices. One final thought, please do not forget about the risk-management piece (EN ISO 14971:2009). Similar to the competent authorities in Europe and the US FDA, the Japanese are quite fond of risk management.
A mission-critical deliverable associated with an effective product realization process is the identification of the requirements needed to support design and development and the eventual approval of the device application by PMDA. As a minimum, device manufacturers must:
- Translate the customer-specific requirements (including delivery and post-market surveillance activities);
- Be clairvoyant in support of identifying customer requirements not specified but necessary to support the intended use of the device;
- Identify and comply with all applicable regulatory and statutory requirements (remember there is no such thing as minimum compliance, or maximum compliance, there is just compliance); and
- Identify necessary requirements, deemed applicable by the device manufacturer.
Another extremely important point device manufacturers should keep in mind is not to commit to accepting customer orders they cannot fulfill. Dr. D, do you mean to tell the readers that a device manufacturer would accept an order without first reviewing the requirements? That is right folks, it happens and it happens more frequently than most expect. That being said, similar to ISO 13485, MO 169 requires an actual documented review of product requirements prior to a device manufacturer making a decision to supply a device. For example, if a device company’s core competency is the design, development, and manufacture of urinary drainage catheters, they should not be accepting orders for electrophysiological catheters. This logic makes sense to the old doctor and hopefully it will make sense to the readers. In support of product realization, device manufacturers must:
- Ensure product requirements identified during the review process are documented;
- Contact the customer, if the customer throws that proverbial “curve ball” and changes previously-ordered product requirements; and
- Ensure they have the capability and capacity to actually manufacturer medical devices in accordance with defined requirements.
Who knew? Device manufacturers must actually have the ability to manufacture medical devices. What a novel concept? Since this requirement has been placed into a regulation, some folks must be missing the boat when it comes to this simple but crucial point.
Dr. D broken-record time again folks; as much as the doctor would like to believe that documenting the review of customer requirements (in writing) would be obvious and intuitive to the most casual observer, it is simply not the case. So Dr. D will make it easy to remember; “Document the @#$% reviews of customer requirements!” Why? If one has to ask then they are probably in the wrong industry.
A couple of final points needed to be made by the doctor can be categorized as no-brainers. If a customer fails to provide documented requirements, it is incumbent upon the device manufacturer to call and attempt to determine their customer’s requirements, before accepting the order. The doctor is not sure why a device manufacturer would even consider accepting an order with no documented requirements. Can you say purchase order please? If a customer has requested a product change, a device manufacturer is actually expected to implement those changes. Who knew? Dr. D knows that there is way too much common sense being written here; however, failure to implement customer changes continues to happen. If these types of errors are being made, then just maybe it is time to explore business options outside of the device industry, like a bartender.
Finally, customer communication is paramount to an effective product realization process. As the doctor has previously stated, you never want to hear the words; “What we have here is a failure to communicate.” Device manufacturers are expected to:
- Communicate customer information;
- Communicate information pertaining to contracts, inquiries. Order handling, etc.;
- Communicate and provide feedback, this also means customer complaints; and
- Communicate and issue product advisory notices (when deemed applicable). Hopefully the readers catch the doctor’s drift in regards to the importance of communication.
What device manufacturers need to do
Just comply baby, comply! For those of you that have read the previous DG articles on MO 169, then the doctor’s next sentence should be no surprise. Dr. D strongly recommends building the requirements/compliance matrix, mapping your organization’s QMS to MO 169 (reference Table 1.0). The doctor also recommends ensuring that 360-degree-reviews occur when reviewing customer requirements. For example, as a quality and regulatory professional, the doctor would feel slighted if only manufacturing engineering reviewed customer requirements before committing to order acceptance. In fact, these reviews should be performed by quality, regulatory, manufacturing, engineering, supply chain, purchasing, planning, sales, marketing and anyone and everyone that can add value to the review process. Broken-record time again, document the reviews as this documentation can be used to provide evidence of compliance, if PMDA chooses to visit your facility for a friend visit, and an inspection. Finally, the doctor is sure the readers would never accept a wooden nickel from a stranger, so ensure your organization does not accept orders without documented requirements (regardless of the value of the order). Trust Dr. D when I say; “You will be sorry.”
| 21 CFR, Part 820
| EN ISO 13485:2003
| MHLW MO 169
| 1249-1 Rev A
|| Planning of Product Realization
|| Article 26
| 1249-1 Rev B
|| Determination of Requirements Related to Products
|| Article 27
| 1249-1 Rev C
|| Review of Requirements Related to Products
|| Article 28
| 1249-1 Rev D
|| Customer Communication
Dr. D will leave the readers with three takeaways from this week’s guidance. (1) Perform a thorough cross-functional review of all customer requirements before accepting the order. (2) Make sure the reviews of customer requirements are documented (in writing); otherwise, there is no evidence of the review actually occurring. (3) You would not accept a wooden nickel from a stranger so why would you accept an order without written customer requirements. Until the next edition of DG, when the doctor begins providing guidance on MO 169 – Chapter 2, Section 5 “Product Realization” (Articles 30 through 36 – Design and Development Planning), sayonara from Dr. D and best wishes for continued professional success.
- Code of Federal Regulation. (2011, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
- Japan medical device approval and certification. (2012, July). The Emergo Group Website. Retrieved July 29, 2012, from http://www.emergogroup.com/services/japan/medical-device-approval-japan.
- Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf.
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